The new trade deal between the United States, Canada and Mexico gives makers of brand biologics 10 years of data exclusivity, even though Canadian law grants eight years of protection, and the deal includes a “robust scope of product eligibility for protection,” according to a summary from the U.S. Trade Representative Office.

FDA on Friday (Sept. 28) issued two draft guidances that agency chief Scott Gottlieb says will lower the cost of drug development, making it easier for sponsors to bring second and third drugs in a class to market.

In another step toward bringing competition to an expensive, top-selling rheumatoid arthritis drug, FDA is reviewing Samsung Bioepis’ application for a biosimilar of Humira, according to a release by Bioepis.

The Drug Enforcement Administration has placed the first FDA-approved cannabidiol (CBD) drug, Epidiolex, under Schedule V of the Controlled Substances Act, and manufacturer GW Pharmaceuticals says the drug should be available in the next six weeks.

The sweeping opioid deal passed by the House Friday (Sept. 28) includes new language aimed at closing a loophole in separate gag-order legislation that requires makers of biologics to report to the Federal Trade Commission settlements that could delay biosimilar competition.

HHS on Friday (Sep. 28) announced about $2.6 million in prize money for the KidneyX: Redesign Dialysis competition, and Ed Simcox, HHS chief technology officer, said at a briefing that the while the prize competition can encourage innovation, coordination between FDA and CMS to improve patient access will also be part of the KidneyX initiative.

FDA Deputy Commissioner Anna Abram urged compounders to be more proactive in keeping their facilities clean, and issued a revised draft guidance on the issue aimed at helping compounders identify unclean conditions in their facilities and implement corrective actions, as well helping state health agencies on their day-to-day oversight.

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

The final version of opioid legislation excludes brand-drug industry-backed Part D changes, and now brand lobbyists have set their sights on the lame-duck session for getting Congress to lower the industry’s share of seniors’ drug costs.

The final opioid legislation unveiled by House and Senate negotiators late Tuesday (Sept. 25) includes two controversial provisions -- one expanding Medicaid payments for opioid-abuse treatment in large inpatient facilities and another allowing non-physician providers to prescribe a drug used to treat opioid addiction.

The final opioid legislation negotiated by House and Senate negotiators includes a number of FDA-focused provisions, including measures to expand the agency’s authorities in international mail facilities; allow the agency to impose certain packaging and disposal requirements for drugs that pose serious risks; and let FDA require labeling changes for drugs when new effectiveness information emerges.

The opioid legislation hammered out by House and Senate conferees includes a requirement that HHS, in consultation with FDA and other relevant agencies, develop materials describing the circumstances under which a pharmacist may decline to fill a prescription for a controlled substance.

The Trump administration has proposed a rule that would allow the government to deny green cards for immigrants who receive Medicare Part D low-income subsidies or Medicaid, but, in a departure from leaked drafts, the proposal wouldn’t target immigrants who receive Affordable Care Act subsidies.

FDA issued two guidances on Monday (Sept. 24) -- one final and one draft -- aimed at streamlining the review process for generic, brand and biologics drugs and helping developers submit high-quality applications from the get-go to avoid going through multiple review cycles, the agency announced Monday (Sept. 24).

Senate Minority Leader Chuck Schumer (D-NY) is the key lawmaker in brand drug makers’ play to get Congress to lower their share of seniors’ drug costs, sources on both sides of the lobbying effort say.

Former CMS officials, a Democrat and a Republican, discussed the intense political pressure CMS staff would be subject to if Medicare were to negotiate drug prices, and they said the current system is preferable.

Brand drug makers have inched closer to getting Congress to lower their share of seniors’ drug costs by adding to opioid legislation an unrelated package that combines the brand-backed Part D measure with watered-down pro-generic legislation and a provision that averts steep drug cost increases for seniors in 2020.